FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TIP-VU
K Number: K811822
·
Decision Jul 20, 1981
Classifications
1
FEI Numbers
231
Registration Numbers
231
Same Product Code
66
Applicant Total
10
Review Days
21
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Basic Information
- Device Name
- TIP-VU
- K Number
- K811822
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Instranetics, Inc.
- Date Received
- June 29, 1981
- Decision Date
- July 20, 1981
- Product Code
- KDC
- 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 |
|---|---|---|---|
| KDC | Instrument, Surgical, Disposable | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KDC), ordered by most recent decision date.
DISPOSABLE SURGICAL SCISSORS AND FORCEPS
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SURGIMED BREAST LOCALIZATION NEEDLE WIRE SET
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·General, Plastic Surgery
THERMUFF BAG
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MANUAL SURGICAL INSTRUMENTS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DISPOSABLE CAUTERY ABRASIVE PAD
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
INSTRUMENT ORGANIZER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Instranetics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K823430 | INSTRA-SAFE | Jan 7, 1983 | Substantially Equivalent |
| K811824 | CAUTERY CADDY PAD | Jul 20, 1981 | Substantially Equivalent |
| K811823 | SHARPS CADDY FB | Jul 20, 1981 | Substantially Equivalent |
| K810294 | LINE CADDY | Feb 26, 1981 | Substantially Equivalent |
| K810208 | BLADE SAFE | Feb 12, 1981 | Substantially Equivalent |
| K802865 | SAFE T COUNT | Dec 18, 1980 | Substantially Equivalent |
| K802866 | SHARPS CADDY MAGNETIC & SHARPS CADDY FOA | Nov 17, 1980 | Substantially Equivalent |
| K781575 | DISPOSABLE LYMPHANGIOGRAM SET | Dec 4, 1978 | Substantially Equivalent |
| K770894 | NEURO-SORB PATTIES | Jun 20, 1977 | Substantially Equivalent |