FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
O.R. SCRUB PREP TRAY, STERILE, DISPOSABLE
K Number: K965201
·
Decision Feb 14, 1997
Classifications
1
FEI Numbers
159
Registration Numbers
159
Same Product Code
109
Applicant Total
44
Review Days
50
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- O.R. SCRUB PREP TRAY, STERILE, DISPOSABLE
- K Number
- K965201
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- Trinity Laboratories, Inc.
- Date Received
- December 26, 1996
- Decision Date
- February 14, 1997
- Product Code
- LRO
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LRO | General Surgery Tray | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LRO), ordered by most recent decision date.
Medline General Surgery Tray
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Medline Cardiovascular Procedure Kit
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SURGICAL DRAPE KIT - D.I.R.R.A. SRL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AMSINO TRACHEOSTOMY CARE TRAY
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY PROCEDURE TRAY
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Trinity Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K981441 | HEART CATH TRAY, STERILE, DISPOSABLE | Jul 10, 1998 | Substantially Equivalent |
| K974238 | DENTAL TRAY, STERILE, DISPOSABLE | Feb 4, 1998 | Substantially Equivalent |
| K974286 | CIRCUMCISION TRAY, CAT. NO. 70340 | Dec 12, 1997 | Substantially Equivalent |
| K972160 | CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATION LATEX TEST | Aug 1, 1997 | Substantially Equivalent |
| K970722 | EYE TRAY | Mar 31, 1997 | Substantially Equivalent |
| K964921 | BASIC BIOPSY TRAY. DISPOSABLE, STERILE | Jan 22, 1997 | Substantially Equivalent |
| K953929 | MID-STREAM COLLECTION SET-STERILE | Nov 16, 1995 | Substantially Equivalent |
| K952058 | STERILE V.A.D. (VASCULAR ACCESS DEVICES) ACCESS KIT, DISPOSABLE | Sep 21, 1995 | Substantially Equivalent |
| K953070 | WOUNDFOAM 4 X 4 | Sep 8, 1995 | Substantially Equivalent |
| K951506 | SUCTION CATHETER KIT, STERILE, SINGLE-USE | Jul 3, 1995 | Substantially Equivalent |