OPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAY— 510(k) K971061

Name: FDA 510(k) clearance K971061
Creator: U.S. Food and Drug Administration
Published: 1997-06-11

Substantially Equivalent for Some Indications

Opportunity, Inc.

FDA 510(k) clearance K971061 for OPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAY, Substantially Equivalent for Some Indications on 1997-06-11. Applicant: Opportunity, Inc.. Device class: 2.

Clearance details

Applicant: Opportunity, Inc.
Product code: Code LRO
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1997-03-24
Decision date: 1997-06-11
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Highland Park, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LRO

view all

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

More clearances from Opportunity, Inc.

view all

K971088 — OPPORTUNITY INCISION AND DRAINAGE TRAY1997-09-16
K971089 — OPPORTUNITY, INC. LACERATION TRAY1997-09-16
K971090 — OPPORTUNITY DRESSING CHANGE TRAY1997-09-16
K971091 — OPPURTUNITY TRACHEOSTOMY CARE KIT1997-09-16
K971093 — OPPORTUNITY I.V. START KIT1997-09-16

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.