FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TUBE, LEATHERMAN/IMBRUCE
K Number: K781665
·
Decision Dec 15, 1978
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
4
Applicant Total
8
Review Days
78
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Basic Information
- Device Name
- TUBE, LEATHERMAN/IMBRUCE
- K Number
- K781665
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- National Catheter Co. Div. Mallinckrodt
- Date Received
- September 28, 1978
- Decision Date
- December 15, 1978
- Product Code
- GBA
- 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 |
|---|---|---|---|
| GBA | Catheter, Balloon Type | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GBA), ordered by most recent decision date.
BYRON WORD BARTHOLIAN GLAND CATHETER
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BALLOON RETENTION CHEST CATHETER
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ELECATH MULTI-PURPOSE ARTERIAL SURGER
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CATHETER, TRANSLUMINAL BALLOON
FDA 510(k)
FDA Class 1
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Other Clearances by National Catheter Co. Div. Mallinckrodt
| K Number | Device Name | ||
|---|---|---|---|
| K802918 | ANTHRON CATHETER SET | Apr 21, 1981 | Substantially Equivalent |
| K802505 | DOUBLE LUMEN TRACHEAL TUBE | Mar 13, 1981 | Substantially Equivalent |
| K810321 | REINFORCED TRACHEOSTOMY TUBE SET(TENTAT) | Mar 4, 1981 | Substantially Equivalent |
| K801924 | HI-LO TEMP GEN. PURPOSE TEMP. PROBE | Sep 9, 1980 | Substantially Equivalent |
| K801005 | MLT TUBE MICROLARYNGEAL TRACHEAL TUBE) | May 23, 1980 | Substantially Equivalent |
| K791190 | STETHOSCOPE WITH TEMPERATURE SENSOR | Jul 6, 1979 | Substantially Equivalent |
| K770727 | MANIPULATOR & INJECTOR, UTERINE | Apr 26, 1977 | Substantially Equivalent |