FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SUTURE-AID BOOTIES
K Number: K832441
·
Decision Mar 5, 1984
Classifications
1
FEI Numbers
231
Registration Numbers
231
Same Product Code
66
Applicant Total
9
Review Days
224
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
- SUTURE-AID BOOTIES
- K Number
- K832441
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Omega-Med Intl., Inc.
- Date Received
- July 25, 1983
- Decision Date
- March 5, 1984
- Product Code
- KDC
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| KDC | Instrument, Surgical, Disposable | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KDC), ordered by most recent decision date.
DISPOSABLE SURGICAL SCISSORS AND FORCEPS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SURGIMED BREAST LOCALIZATION NEEDLE WIRE SET
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
THERMUFF BAG
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MANUAL SURGICAL INSTRUMENTS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DISPOSABLE CAUTERY ABRASIVE PAD
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
INSTRUMENT ORGANIZER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Omega-Med Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K842603 | OMED DISPOS. INSTRUMENT GUARDS | Sep 5, 1984 | Substantially Equivalent |
| K830484 | OMED IDENT-I-BAND | Mar 24, 1983 | Substantially Equivalent |
| K822284 | COMPLY NEUROMUSCULAR STIMULATOR | Sep 17, 1982 | Substantially Equivalent |
| K821334 | OMED FABRIC INSTRUMENT COVERS-RADIOPAQ | May 24, 1982 | Substantially Equivalent |
| K813499 | OMED DISPOSABLE BULLDOG | Dec 29, 1981 | Substantially Equivalent |
| K810883 | OMED SILICONE INSTRUMENT COVERS | Apr 23, 1981 | Substantially Equivalent |
| K810269 | OMED FABRIC INSTRUMENT COVERS | Feb 26, 1981 | Substantially Equivalent |
| K810260 | OMED SILICONE LOOPS | Feb 26, 1981 | Substantially Equivalent |