Grasping Forceps, Biopsy Forceps, Scissors, Punch

by Richard Wolf Medical Instruments Corp. 510(k)

Active United States Open recall

510(k) K953868

Regulatory status

as of 29 Oct 2026

Recall ongoing. 1 ongoing FDA recall names this device. See recalls

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK953868	Date29 Sep 1995Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Recalls

1 recall · 1 ongoing · FDA

- Ongoing Z-2897-2018 FDA Class II initiated 24 Jul 2017
Punch may have a burr in one section of the joint and when the punch is open, there is an increase potential for injury.

Specification

510(k)

510(k) Number: K953868
FDA Product Code: HRX

Device Class: Class II
Regulation: 21 CFR Part 888.1100
Advisory Committee: Orthopedic
FDA Decision: SESE Substantially Equivalent

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