510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K050256Substantially Equivalent

Apple Medical/ob Mobius Elastic Retractor

CooperSurgical, Inc., Boston MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K050256 is the FDA 510(k) clearance record for APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR, a class I device, cleared for Apple Medical Corp. on under FDA product code GAD (Retractor). FDA records list 103 510(k) clearances for COOPERSURGICAL, INC., from to . As of , FDA records show no recalls naming K050256.

Clearance record

Decision date
Received
(82 days to decision)
Product code
GAD Retractor
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Apple Medical Corp. 75 Federal St., Boston MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GAD

Trailing 12 months

FDA records hold no clearances under product code GAD in the trailing twelve months.

FDA records show no clearances under product code GAD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GAD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260