KINDERWRAP
FDA 510(k) clearance K872003 · decided 1987-06-23
Clearance details
- K-number
- K872003
- Device name
- KINDERWRAP
- Applicant
- The Kinder Co.
- Decision
- Substantially Equivalent
- Date received
- 1987-05-26
- Decision date
- 1987-06-23
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- GAX
- Device class
- 1
- Regulation number
- 878.5900
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Ypsilanti, MI, 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 |
|---|---|---|
| UNIQUET (K931198) | Icat Systems | 1993-09-01 |
| TOURNIQUET (K881398) | Barretta Products, Research and Development, Inc. | 1988-04-29 |
| STERILE ESMARCH BANDAGE (K881176) | Spectrum/Hydro-Med Products, Inc. | 1988-04-11 |
| DEGANIA SILICONE TOURNIQUET (K875092) | Degania Silicone , Ltd. | 1988-01-07 |
| UNIVERSAL TOURNIQUET (K873928) | Dryden Corp. | 1987-10-23 |
| DALE VENIPUNCTURE TOURNIQUET, PRODUCT NO. 1335 (K864897) | Dale Medical Products, Inc. | 1987-01-12 |
| FINGER TOURNIQUETTE (K853472) | Joseph B. Marogil | 1985-10-10 |
| VELCRO TOURNIQUET (K853537) | Cp Medical | 1985-09-12 |
| CATAPRESS TOURNIGUET (K852277) | Boehringer Ingelheim Pharmaceuticals, Inc. | 1985-06-27 |
| TOURNIQUET (K851482) | Polymer Technology Corp. | 1985-04-29 |
| ELASTIC BANDAGE (K843056) | Sterile Medical Systems | 1984-12-04 |
| DISPOSIQUET A DISPOS. TOURNIQUET (K840489) | Med Lab Products | 1984-03-12 |
Recalls involving this device
No recalls on record reference this clearance.