FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
LOREX TRACHEOSTOMY GAUZE SPONGES - STERILE 1'S AND 2'S
K Number: K941955
·
Decision May 12, 1994
Classifications
1
FEI Numbers
63
Registration Numbers
63
Same Product Code
270
Applicant Total
16
Review Days
20
Basic Information
- Device Name
- LOREX TRACHEOSTOMY GAUZE SPONGES - STERILE 1'S AND 2'S
- K Number
- K941955
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- LORREX HEALTH PRODUCTS
- Date Received
- April 22, 1994
- Decision Date
- May 12, 1994
- 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 LORREX HEALTH PRODUCTS
| K Number | Device Name | ||
|---|---|---|---|
| K945335 | CHERRY DISSECTOR | Dec 28, 1994 | Substantially Equivalent |
| K945333 | KITTNER DISSECTOR | Dec 28, 1994 | Substantially Equivalent |
| K945866 | CYLINDRICAL SPONGE | Dec 28, 1994 | Substantially Equivalent |
| K945606 | TRIANGULAR SPONGES | Dec 28, 1994 | Substantially Equivalent |
| K945553 | ROUND STICK SPONGES, FLAT STICK SPONGES | Dec 28, 1994 | Substantially Equivalent |
| K945336 | PEANUT DISSECTOR | Dec 5, 1994 | Substantially Equivalent |
| K945332 | ROSEBUD DISSECTOR | Dec 5, 1994 | Substantially Equivalent |
| K945334 | CHERRY PIT DISSECTOR | Dec 5, 1994 | Substantially Equivalent |
| K942824 | LORREX IV SPONGES, STERILE 2'S; LORREX DRAIN SPONGES, STERILE 2'S | Aug 3, 1994 | Substantially Equivalent |
| K942314 | LORREX GAUZE SPONGES SPECIALTY | Jun 2, 1994 | Substantially Equivalent |