MITEK SUTURE RETROGRADER— 510(k) K970360

Name: FDA 510(k) clearance K970360
Creator: U.S. Food and Drug Administration
Published: 1997-03-10

Substantially Equivalent

Mitek Products

FDA 510(k) clearance K970360 for MITEK SUTURE RETROGRADER, Substantially Equivalent on 1997-03-10. Applicant: Mitek Products. Device class: 1.

Clearance details

Applicant: Mitek Products
Product code: Code HWQ
Device class: Class 1
Regulation: 21 CFR 888.4540
Advisory panel: Orthopedic
Date received: 1997-01-31
Decision date: 1997-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westwood, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HWQ

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K920621 — ACUFEX PASSING PINS AND SURGICAL WIRE1993-05-05
K923381 — SOFT TISSUE EXPANDER1993-05-05
K885311 — MENISCUS MENDER II LOOP1989-02-09
K843592 — VICO MICRO SURGICAL INSTRUMENTS1984-10-05
K841622 — SOFT-TISSUE INSTRUMENT1984-07-11

More clearances from Mitek Products

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K013572 — MITEK BIOCRYL INTERFERENCE SCREWS2002-03-14
K013781 — RIDIDFIX 2.7MM BTB CROSS PIN KIT2002-02-06
K002639 — BIOKNOTLESS ANCHOR2001-05-11
K010633 — RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM2001-05-09
K002406 — MITEK 2GII MENISCAL REPAIR SYSTEM2001-02-15

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.