510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K881265Substantially Equivalent

Raney Clips

Zimmer GmbH, Warsaw IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881265 is the FDA 510(k) clearance record for RANEY CLIPS, a class II device, cleared for Zimmer, Inc. on under FDA product code HBO (Clip, Scalp). FDA records list 872 510(k) clearances for Zimmer, Inc., from to . As of , FDA records show no recalls naming K881265.

Clearance record

Decision date
Received
(68 days to decision)
Product code
HBO Clip, Scalp
Regulation
21 CFR 882.4150
Device class
Class II
Review panel
Neurology
Applicant
Zimmer, Inc. P.O. Box 708, Warsaw IN
Third party review
No

Clearances, product code HBO

Trailing 12 months
1 clearance under product code HBO in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HBO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260