MENISCUS MENDER II LOOP— 510(k) K885311

Name: FDA 510(k) clearance K885311
Creator: U.S. Food and Drug Administration
Published: 1989-02-09

Substantially Equivalent

Instrument Makar, Inc.

FDA 510(k) clearance K885311 for MENISCUS MENDER II LOOP, Substantially Equivalent on 1989-02-09. Applicant: Instrument Makar, Inc.. Device class: 1.

Clearance details

Applicant: Instrument Makar, Inc.
Product code: Code HWQ
Device class: Class 1
Regulation: 21 CFR 888.4540
Advisory panel: Orthopedic
Date received: 1988-12-29
Decision date: 1989-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Okemos, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HWQ

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K970360 — MITEK SUTURE RETROGRADER1997-03-10
K920621 — ACUFEX PASSING PINS AND SURGICAL WIRE1993-05-05
K923381 — SOFT TISSUE EXPANDER1993-05-05
K843592 — VICO MICRO SURGICAL INSTRUMENTS1984-10-05
K841622 — SOFT-TISSUE INSTRUMENT1984-07-11

More clearances from Instrument Makar, Inc.

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K002600 — LITWIN CRUICATE ANCHOR2000-11-15
K980999 — ST LEGER CEMENTED SEMI-CONSTRAINED TOTAL KNEE IMPLANT1998-11-06
K963396 — BIOSPHERE SUTURE ANCHOR1997-05-06
K964364 — DISPOSABLE APRON1997-02-25
K955835 — FLUID BARRIER BOOT KNEE & ANKLE-HIGH1996-11-19

Adverse events under product code HWQ

product code HWQ

Injury: 137
Malfunction: 443
Total: 580

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.