Atlas FDA

BIOPSY TRAY I & II

FDA 510(k) clearance K854095 · decided 1985-11-25

Clearance details

K-number
K854095
Device name
BIOPSY TRAY I & II
Applicant
North Coast Medi-Tek
Decision
Unknown
Date received
1985-10-07
Decision date
1985-11-25
Days to decision
49 days
Clearance type
Traditional
Product code
LRO
Device class
2
Regulation number
878.4370
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Eastlake, OH, US
Third-party review
No
Expedited review
No

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AMSINO TRACHEOSTOMY CARE TRAY (K023276)Amsino International, Inc.2002-12-09
WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY PROCEDURE TRAY (K980137)Worldwide Medical Technologies, LLC1998-01-30
OPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAY (K971061)Opportunity, Inc.1997-06-11
OPPORTUNITY INC. GENERAL PURPOSE TRAY (K971062)Opportunity, Inc.1997-06-09
NEUROLOGICAL OR CRANI TRAYS (PACKS) (K932221)Associated Medical Products Co.1997-03-19
PRESBYTERIAN LINEN SERVICES SURGICAL PACKS (K970286)Medline Industries, Inc.1997-03-10
O.R. SCRUB PREP TRAY, STERILE, DISPOSABLE (K965201)Trinity Laboratories, Inc.1997-02-14
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Recalls involving this device

RecordFirmDate
Biopsy Trays (CT, Puncture & Prep), Packaged individually in header bags, 10 per case. Ste recall (Z-2982-2011)North Coast Medi-Tek Inc2011-08-10
SourceOne Healthcare Technologies brand, Ultrasound Tray, Cat. 255825R1, Lot 0503, Exp. 11 recall (Z-1572-05)North Coast Medi-Tek Inc2005-09-21
E-Z-EM brand, Basic biopsy tray, catalog no. 4125. recall (Z-1523-05)North Coast Medi-Tek Inc2005-09-08