FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
DRESSING CHANGE TRAYS & STERILE SPONGES
K Number: K811951
·
Decision Oct 16, 1981
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
270
Applicant Total
14
Review Days
101
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Basic Information
- Device Name
- DRESSING CHANGE TRAYS & STERILE SPONGES
- K Number
- K811951
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- O.R. Specialties, Inc.
- Date Received
- July 7, 1981
- Decision Date
- October 16, 1981
- Product Code
- EFQ
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| EFQ | Gauze/Sponge, Internal | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EFQ), ordered by most recent decision date.
NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE
FDA 510(k)
FDA Unclassified
·Unknown
SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S
FDA 510(k)
FDA Unclassified
·Unknown
VITOP DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE
FDA 510(k)
FDA Unclassified
·Unknown
CROSSTEX NON-WOVEN SPONGES
FDA 510(k)
FDA Unclassified
·Unknown
GAUZE, SPONGES, CAT # 11-003
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by O.R. Specialties, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K942607 | LAPAROSCOPIC SCISSORS (DISPOSABLE) | Jul 6, 1994 | Substantially Equivalent |
| K923630 | PHACO NEEDLES 1000-R & 1000-O NEEDLES | Apr 6, 1994 | Substantially Equivalent |
| K925671 | DISPOSABLE SCLERAL PLUGS | Aug 2, 1993 | Substantially Equivalent |
| K923887 | JACK'S VENT TUBES | Feb 19, 1993 | Substantially Equivalent |
| K923774 | DISPOSABLE ENDOILLUMINATOR | Oct 19, 1992 | Substantially Equivalent |
| K922355 | POLLY'S VITREOUS SCISSORS J-225-S | Aug 18, 1992 | Substantially Equivalent |
| K922180 | LEWICKY O.R.S. TUBING | Jul 2, 1992 | Substantially Equivalent |
| K914038 | POLLY'S CUTTER J-225 | Dec 9, 1991 | Substantially Equivalent |
| K911932 | J105 JAMES SURGICAL SYSTEM I/A PACK | Aug 26, 1991 | Substantially Equivalent |
| K890195 | JAMES SURGICAL SYSTEM J1000 | Aug 3, 1989 | Substantially Equivalent |