FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LORREX GAUZE SPONGES, X-RAY DETECTABLE
K Number: K942366
·
Decision May 27, 1994
Classifications
1
FEI Numbers
211
Registration Numbers
211
Same Product Code
110
Applicant Total
16
Review Days
9
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Basic Information
- Device Name
- LORREX GAUZE SPONGES, X-RAY DETECTABLE
- K Number
- K942366
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4450
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Lorrex Health Products
- Date Received
- May 18, 1994
- Decision Date
- May 27, 1994
- Product Code
- GDY
- 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 |
|---|---|---|---|
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GDY), ordered by most recent decision date.
ULTRACELL SUCTION SPONGE
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STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE
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PROTEC X-RAY DETECTABLE GAUZE SPONGE
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KENSORB
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TRIANGULAR SPONGES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Lorrex Health Products
| K Number | Device Name | ||
|---|---|---|---|
| K945553 | ROUND STICK SPONGES, FLAT STICK SPONGES | Dec 28, 1994 | Substantially Equivalent |
| K945866 | CYLINDRICAL SPONGE | Dec 28, 1994 | Substantially Equivalent |
| K945333 | KITTNER DISSECTOR | Dec 28, 1994 | Substantially Equivalent |
| K945606 | TRIANGULAR SPONGES | Dec 28, 1994 | Substantially Equivalent |
| K945335 | CHERRY DISSECTOR | Dec 28, 1994 | Substantially Equivalent |
| K945334 | CHERRY PIT DISSECTOR | Dec 5, 1994 | Substantially Equivalent |
| K945332 | ROSEBUD DISSECTOR | Dec 5, 1994 | Substantially Equivalent |
| K945336 | PEANUT 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 |