STERILE DISPOSABLE SURGICAL PACKS— 510(k) K884093

Name: FDA 510(k) clearance K884093
Creator: U.S. Food and Drug Administration
Published: 1988-10-19

Substantially Equivalent

Bolden Surgical Products

FDA 510(k) clearance K884093 for STERILE DISPOSABLE SURGICAL PACKS, Substantially Equivalent on 1988-10-19. Applicant: Bolden Surgical Products. Device class: 2.

Clearance details

Applicant: Bolden Surgical Products
Product code: Code LRO
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1988-09-28
Decision date: 1988-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winston-Salem, NC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LRO

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K213481 — Medline General Surgery Tray2022-05-24
K212258 — Medline Cardiovascular Procedure Kit2021-12-03
K041080 — SURGICAL DRAPE KIT - D.I.R.R.A. SRL2004-11-30
K030721 — QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE2003-03-31
K023276 — AMSINO TRACHEOSTOMY CARE TRAY2002-12-09

Adverse events under product code LRO

product code LRO

Injury: 975
Malfunction: 14,038
Other: 2
Total: 15,015

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.