Thermuff Bag
by Techstyles
510(k) K920153
Thermuff Bag is a medical device (FDA Class I; FDA product code KDC, Instrument, Surgical, Disposable) made by Techstyles, cleared under FDA 510(k) K920153 on 1 Jul 1992, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK920153 | Date1 Jul 1992 | StatusActive |
Official records
- FDA 510(k) database K920153
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KDC
- Device class
- Class I
- Regulation
- 21 CFR Part 878.4800
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
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