IOP ADJUSTABLE STIRRUP— 510(k) K884558

Name: FDA 510(k) clearance K884558
Creator: U.S. Food and Drug Administration
Published: 1988-11-17

Substantially Equivalent

Mend Technologies, Inc.

FDA 510(k) clearance K884558 for IOP ADJUSTABLE STIRRUP, Substantially Equivalent on 1988-11-17. Applicant: Mend Technologies, Inc.. Device class: 1.

Clearance details

Applicant: Mend Technologies, Inc.
Product code: Code BWN
Device class: Class 1
Regulation: 21 CFR 878.4950
Advisory panel: General, Plastic Surgery
Date received: 1988-10-31
Decision date: 1988-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BWN

view all

K942699 — AIRFRAME SURGICAL DRAPE SUPPORT1994-07-13
K935441 — INFINITECH BREATH EZ1994-02-07
K925005 — ISI SELF-SUPPORTING ARM1993-04-29
K922288 — HOLDER, PEDIATRIC POSITION1993-02-10
K910783 — SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M1991-04-02

More clearances from Mend Technologies, Inc.

view all

K924094 — MEND APC1993-03-30
K883867 — CERVICAL BIOPSY INSTRUMENT1988-11-29

Adverse events under product code BWN

product code BWN

Other: 1
Total: 1

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.