FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SURGICAL 'LASER' DRAPE
K Number: K884231
·
Decision Apr 20, 1989
Classifications
1
FEI Numbers
200
Registration Numbers
200
Same Product Code
449
Applicant Total
44
Review Days
195
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SURGICAL 'LASER' DRAPE
- K Number
- K884231
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Henley Intl.
- Date Received
- October 7, 1988
- Decision Date
- April 20, 1989
- Product Code
- KKX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| KKX | Drape, Surgical, Antimicrobial | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KKX), ordered by most recent decision date.
BeneHold Surgical Incise Drape with CHG antimicrobial II
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BeneHold Surgical Incise Drape with CHG antimicrobial
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ControlRad Sterile Cover
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MediClear PreOp
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Plus Surgical Drapes (EO Sterilized), PMDB-XXX
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Henley Intl.
| K Number | Device Name | ||
|---|---|---|---|
| K943449 | NEUROLOGICAL DIAGNOSTIC DEVICES | Nov 15, 1995 | Substantially Equivalent |
| K926279 | UPPER BODY EXERCISER | May 5, 1994 | Substantially Equivalent |
| K926278 | STAIR CLIMBER | May 5, 1994 | Substantially Equivalent |
| K926287 | EXERCISE BICYCLE | Mar 22, 1994 | Substantially Equivalent |
| K926314 | HYDRA FITNESS MODEL 311 TOTAL POWER | Mar 18, 1994 | Substantially Equivalent |
| K926313 | COMPUTERIZED TESTING AND EXERCISE SYSTEMS | Feb 4, 1994 | Substantially Equivalent |
| K915864 | MONOTRODE CUTANEOUS ELECTRODE | Jul 21, 1993 | Substantially Equivalent |
| K922036 | SONOPULS 591 | Jun 29, 1993 | Substantially Equivalent |
| K926316 | TRUE-TRAC, STRATUS | Mar 24, 1993 | Substantially Equivalent |
| K920983 | SONOPULS 590 | Mar 9, 1993 | Substantially Equivalent |