FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SURG-A-STAT VASECTOMY TIP
K Number: K840370
·
Decision Jul 23, 1984
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
22
Applicant Total
31
Review Days
178
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Basic Information
- Device Name
- SURG-A-STAT VASECTOMY TIP
- K Number
- K840370
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Suncoast Medical Manufacturers, Inc.
- Date Received
- January 27, 1984
- Decision Date
- July 23, 1984
- Product Code
- GET
- 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 |
|---|---|---|---|
| GET | Motor, Surgical Instrument, Pneumatic Powered | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
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ROTATING, FIXED FOOTED, FIXED SHIELD ATTACHMENTS, DISSECTING TOOLS
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Other Clearances by Suncoast Medical Manufacturers, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K841604 | ADJUST-A-TEMP HIGH TEMPERATURE | Dec 7, 1984 | Substantially Equivalent |
| K841459 | REPLACE-A-TIP ADJUST. LOW TEMP.- | Dec 7, 1984 | Substantially Equivalent |
| K841509 | REPLACE-A-TIP ADJUSTABLE HIGH TEMP. | Dec 7, 1984 | Substantially Equivalent |
| K841603 | ADJUST-A-TEMP MICRO | Dec 7, 1984 | Substantially Equivalent |
| K841591 | PYRO-TIP | Oct 31, 1984 | Substantially Equivalent |
| K840376 | SURG-A STAT LOOP TIP | Oct 26, 1984 | Substantially Equivalent |
| K840375 | SURG-A-STAT LOOP TIP 15 | Jul 23, 1984 | Substantially Equivalent |
| K840387 | SURG-A-STAT LOOP TIP 2 | Jul 23, 1984 | Substantially Equivalent |
| K840377 | SURG-A-STAT CARDIOVASCULAR TIP | Jul 23, 1984 | Substantially Equivalent |
| K841588 | SUN-LITE WHITE SPOT | May 22, 1984 | Substantially Equivalent |