CEMENT-PICK
FDA 510(k) clearance K822108 · decided 1982-08-11
Clearance details
- K-number
- K822108
- Device name
- CEMENT-PICK
- Applicant
- Bio-Blitz, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-07-19
- Decision date
- 1982-08-11
- Days to decision
- 23 days
- Clearance type
- Traditional
- Product code
- GAF
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Bio-Blitz
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| LEMAITRE VASCULAR DISPOSABLE VEIN STRIPPER (K023688) | LeMaitre Vascular, Inc. | 2003-01-30 |
| SNAP RECIPROCATING SAW (K935357) | Surgiquip, Inc. | 1994-01-28 |
| ABDOMINAL SPATULA (K890374) | Kinetic Medical Products | 1989-02-03 |
| PMT FUKUSHIMA MICROSURGICAL INSTRUMENT LINE (K882793) | Pmt Corp. | 1988-07-18 |
Recalls involving this device
No recalls on record reference this clearance.