FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
TRACHEOTOMY SPONGES
K Number: K880909
·
Decision Mar 17, 1988
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
270
Applicant Total
23
Review Days
14
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
- TRACHEOTOMY SPONGES
- K Number
- K880909
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Ormed Mfg., Inc.
- Date Received
- March 3, 1988
- Decision Date
- March 17, 1988
- 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 Ormed Mfg., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K931555 | ARTROMOT K2 CPM | Jan 31, 1994 | Substantially Equivalent |
| K882528 | CYLINDRICAL SPONGE | Jul 18, 1988 | Substantially Equivalent |
| K882530 | TAPE STRUNG TONSIL SPONGE | Jul 18, 1988 | Substantially Equivalent |
| K882529 | BUTCHER STRUNG TONSIL SPONGE | Jul 18, 1988 | Substantially Equivalent |
| K882527 | GAUZE SPONGE | Jul 18, 1988 | Substantially Equivalent |
| K880853 | CHERRY SPONGE | Mar 17, 1988 | Substantially Equivalent |
| K880907 | TRIANGLE SPONGE | Mar 17, 1988 | Substantially Equivalent |
| K880910 | ROUND STICK SPONGES | Mar 17, 1988 | Substantially Equivalent |
| K880911 | BLUNT SPONGE | Mar 17, 1988 | Substantially Equivalent |
| K880851 | FLAT STICK SPONGE | Mar 17, 1988 | Substantially Equivalent |