510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K901715Substantially Equivalent

Klein Cork(tm)

Jeff Klein Surgical, Inc., San Clemente CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901715 is the FDA 510(k) clearance record for KLEIN CORK(TM), a class I device, cleared for Jeff Klein Surgical, Inc. on under FDA product code GCE (Adaptor, Catheter). FDA records list 5 510(k) clearances for Jeff Klein Surgical, Inc., from to . As of , FDA records show no recalls naming K901715.

Clearance record

Decision date
Received
(28 days to decision)
Product code
GCE Adaptor, Catheter
Regulation
21 CFR 878.4200
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Jeff Klein Surgical, Inc. P.O. Box 1269, San Clemente CA
Third party review
No

Clearances, product code GCE

Trailing 12 months

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

FDA records show no clearances under product code GCE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GCE, 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