FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SURGICAL DRAPE & DRAPE ACCESSORIES
K Number: K863732
·
Decision Oct 23, 1986
Classifications
1
FEI Numbers
200
Registration Numbers
200
Same Product Code
449
Applicant Total
6
Review Days
30
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 DRAPE & DRAPE ACCESSORIES
- K Number
- K863732
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Intera Corp.
- Date Received
- September 23, 1986
- Decision Date
- October 23, 1986
- 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 Intera Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K891686 | LIB SYSTEM, BABY/ADULT DIAPER | May 31, 1989 | Substantially Equivalent |
| K885185 | INTERA SHIELD AND INTERA UNDERGARMENT | Feb 8, 1989 | Substantially Equivalent |
| K883787 | REUSABLE ADULT INCONTINENT DIAPER | Nov 7, 1988 | Substantially Equivalent |
| K883424 | SURGICAL GOWN/SCRUB/LAPAROTOMY/MAYO STAND/BACK TAB | Sep 6, 1988 | Substantially Equivalent |
| K862380 | MATTRESS COVER | Jul 28, 1986 | Substantially Equivalent |