POWER PACK
FDA 510(k) clearance K800314 · decided 1980-03-19
Clearance details
- K-number
- K800314
- Device name
- POWER PACK
- Applicant
- Black & Decker(Tm)
- Decision
- Substantially Equivalent
- Date received
- 1980-02-12
- Decision date
- 1980-03-19
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- KIJ
- Device class
- 1
- Regulation number
- 878.4820
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SMARTO (K163308) | Jeil Medical Corporation | 2016-12-27 |
| INSURGICAL SINGLE USE POWER EQUIPMENT (K112599) | Insurgical, LLC | 2012-11-06 |
| SMARTO (K101563) | Jeil Medical Corporation | 2010-12-17 |
| STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT (K972367) | Stryker Instruments | 1997-09-04 |
| STRYKER 2115 REPLACEMENT BATTERY (2115) (K970378) | Implant Resource, Inc. | 1997-04-30 |
| ACUMED BONE GRAFT SYSTEM (K960711) | Acu Med, Inc. | 1996-05-07 |
| SYSTEM 2000 REPLACEMENT BATTERY, SYSTEM 2000-EXTENDED RUN REPLACEMENT BATTERY (K951450) | Strenumed, Inc. | 1995-05-17 |
| S & S ORTHOPEDIC WIRE DRIVER 701 (K944488) | S & S Orthopedic , Ltd. | 1995-03-02 |
| ARTHREX GRAFT HARVESTING KIT (K941285) | Arthrex, Inc. | 1994-11-14 |
| THE OSTEOMED B POWER SYSTEM AND ACCESSORIES (K933101) | Osteomed Corp. | 1994-11-07 |
| R AND D BATTERY REPLACEMENT (K933337) | R & D Batteries, Inc. | 1994-04-05 |
| SERIES 5000 BATTERY POWERED INSTRUMENT SYSTEM (K931395) | Micro Surgical Instruments Corp. | 1994-01-28 |
Recalls involving this device
No recalls on record reference this clearance.