FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
3M FRASCIA STAPLING SYSTEM
K Number: K823888
·
Decision Jan 9, 1983
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
3
Applicant Total
331
Review Days
13
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Basic Information
- Device Name
- 3M FRASCIA STAPLING SYSTEM
- K Number
- K823888
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- 3M Company
- Date Received
- December 27, 1982
- Decision Date
- January 9, 1983
- Product Code
- GEF
- 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 |
|---|---|---|---|
| GEF | Applier, Staple, Surgical, | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GEF), ordered by most recent decision date.
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FDA Class 1
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MICROAIRE MODEL 2600
FDA 510(k)
FDA Class 1
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V. MUELLER PNEUMO-INTESTINAL 15 VASCULAR & 30 STAP
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
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|---|---|---|---|
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| K241959 | 3M Attest Super Rapid Steam Clear Challenge Pack (1492PCD); 3M Attest Auto-reader (490); 3M Attest Auto-reader (490H); 3M Attest Mini Auto-reader (490M) | Oct 18, 2024 | Substantially Equivalent |
| K241710 | 3M Attest Super Rapid Readout Biological Indicator 1492V; 3M Attest Auto-reader 490; 3M Attest Auto-reader 490H; 3M Attest Mini Auto-reader 490M | Sep 12, 2024 | Substantially Equivalent |
| K241542 | 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD) | Jun 27, 2024 | Substantially Equivalent |
| K240717 | 3M Attest Rapid Readout Biological Indicator 1295 and 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E | Jun 27, 2024 | Substantially Equivalent |
| DEN230068 | 3M Attest eBowie-Dick Test Card 10135 3M Attest eBowie-Dick Card Holder 10135CH 3M Attest eBowie-Dick Auto-reader 1190 | May 21, 2024 | Unknown |
| K233814 | 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M Attest Auto-reader (490); 3M Attest Auto-reader (490H); 3M Attest Mini Auto-reader (490M) | Mar 15, 2024 | Substantially Equivalent |
| K222578 | 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) | May 18, 2023 | Substantially Equivalent |
| K222508 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248 | Nov 1, 2022 | Substantially Equivalent |