FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RICHARD-ALLAN CLAMP COVERS
K Number: K905682
·
Decision Feb 19, 1991
Classifications
1
FEI Numbers
875
Registration Numbers
875
Same Product Code
75
Applicant Total
8
Review Days
62
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Basic Information
- Device Name
- RICHARD-ALLAN CLAMP COVERS
- K Number
- K905682
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Richard-Allan Medical
- Date Received
- December 19, 1990
- Decision Date
- February 19, 1991
- Product Code
- FSM
- 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 |
|---|---|---|---|
| FSM | Tray, Surgical, Instrument | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FSM), ordered by most recent decision date.
INSTRUMENT TRAY LINER
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SINGLE USE INSTRUMENT TRAY
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SURGICAL INSTRUMENT TRAY
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ARTHROSCOPY TRAY
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OPEN HEART TRAY
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HEART CATH TRAY
FDA 510(k)
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·General, Plastic Surgery
Other Clearances by Richard-Allan Medical
| K Number | Device Name | ||
|---|---|---|---|
| K942207 | REFLEX INS INSUFFLATION NEEDLE | May 27, 1994 | Substantially Equivalent |
| K935105 | REFLEX ESP WITH FINGER SWITCHES | Feb 22, 1994 | Substantially Equivalent |
| K933508 | REFLEX SDD SURGICAL STAPLER | Nov 23, 1993 | Substantially Equivalent |
| K933901 | REFLEX(R) EHS (ENDOSCOPIC HERNIA STAPLER) | Nov 19, 1993 | Substantially Equivalent |
| K924881 | REFLEX(R) ESP | Jul 23, 1993 | Substantially Equivalent |
| K924929 | REFLEX(R) ECA | Jul 21, 1993 | Substantially Equivalent |
| K905701 | RICHARD-ALLAN SHEET CLIP | Feb 19, 1991 | Substantially Equivalent |