510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K080412Substantially Equivalent

Absorbable Synthetic Suture with Needle Attachment (Pga Braided)

Shanghai Pudong Jinhuan Medical Products Co., Ltd., La Mirada CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080412 is the FDA 510(k) clearance record for ABSORBABLE SYNTHETIC SUTURE WITH NEEDLE ATTACHMENT (PGA BRAIDED), a class II device, cleared for Shanghai Pudong Jinhuan Medical Products Co., Ltd. on under FDA product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid). FDA records list one 510(k) clearance for Shanghai Pudong Jinhuan Medical Products Co., Ltd. As of , FDA records show no recalls naming K080412.

Clearance record

Decision date
Received
(202 days to decision)
Product code
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Regulation
21 CFR 878.4493
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Shanghai Pudong Jinhuan Medical Products Co., Ltd. Flemington Ct. # 155, La Mirada CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GAM

Trailing 12 months
6 clearances under product code GAM in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code GAM, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20261
March 20260
April 20260
May 20261
June 20261
July 20260
August 20260
September 20261
October 20260