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THE TAPE

Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / October 2025 / K252820

510(k) cleared

PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus)

Internacional Farmacéutica S.A DE C.V · Oct 3, 2025 · K252820

FDA cleared the PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus) from Internacional Farmacéutica S.A DE C.V on Oct 3, 2025 under K252820, a special 510(k). The device falls under product code GAM, Suture, Absorbable, Synthetic, Polyglycolic Acid, regulated at 21 CFR 878.4493 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Sep 4, 2025. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Internacional Farmacéutica S.A DE C.V in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252820?

K252820 is the FDA 510(k) for PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus), submitted by Internacional Farmacéutica S.A DE C.V. FDA's decision date was Oct 3, 2025, under product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid).

Who makes the PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus)?

Internacional Farmacéutica S.A DE C.V, based in Lerma, is the applicant of record for K252820.

How long did the K252820 review take?

FDA received the submission on Sep 4, 2025 and issued its decision on Oct 3, 2025, 29 days later.

← All decisions in October 2025