FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ORTHOPEDIC PACKS
K Number: K951231
·
Decision Dec 1, 1995
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
6
Applicant Total
10
Review Days
256
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Basic Information
- Device Name
- ORTHOPEDIC PACKS
- K Number
- K951231
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4830
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sterile Concepts, Inc.
- Date Received
- March 20, 1995
- Decision Date
- December 1, 1995
- Product Code
- GAN
- 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 |
|---|---|---|---|
| GAN | Suture, Absorbable, Synthetic | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GAN), ordered by most recent decision date.
SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD
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MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED
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·General, Plastic Surgery
MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED)
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FDA Class 2
·General, Plastic Surgery
ULA (POLIGLECAPRONE 251) SYNTHETIC ABSOR SUT, DYED
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FDA Class 2
·General, Plastic Surgery
DEXON II ABSORBABLE SURGICAL SUTURE, U.S.P.
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
POLYSORB SYNTHETIC ABSORBABLE SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Sterile Concepts, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K951081 | OB/GYN PACKS | Nov 13, 1995 | Substantially Equivalent |
| K952539 | RADIOLOGY PACKS | Jul 14, 1995 | Substantially Equivalent |
| K951478 | GENERAL AND PLASTIC SURGERY PACKS | Jun 13, 1995 | Substantially Equivalent |
| K944139 | DENTAL HYGIENE TRAY | Dec 15, 1994 | Substantially Equivalent |
| K943047 | IV START KITS | Sep 14, 1994 | Substantially Equivalent |
| K943090 | SUTURE REMOVAL TRAYS | Aug 22, 1994 | Unknown |
| K940864 | DENTIST WITH ASSISTANT PACK | Aug 2, 1994 | Substantially Equivalent |
| K943046 | SKIN STAPLE REMOVAL TRAYS | Jul 29, 1994 | Unknown |
| K920763 | LACERATTION TRAY | Sep 28, 1992 | Unknown |