FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
KENDALL KERLIX ANTIMICROBIAL SUPER SPONGE DRESSING FOR OTC USE, MODEL 6662
K Number: K070653
·
Decision Sep 12, 2007
Classifications
1
FEI Numbers
384
Registration Numbers
385
Same Product Code
702
Applicant Total
14
Review Days
187
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
- KENDALL KERLIX ANTIMICROBIAL SUPER SPONGE DRESSING FOR OTC USE, MODEL 6662
- K Number
- K070653
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tyco Healthcare
- Date Received
- March 9, 2007
- Decision Date
- September 12, 2007
- Product Code
- FRO
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FRO), ordered by most recent decision date.
Bonvadis®
FDA 510(k)
FDA Unclassified
·Unknown
StatSeal Disc
FDA 510(k)
FDA Unclassified
·Unknown
IWD-Gel
FDA 510(k)
FDA Unclassified
·Unknown
MiraChlor Antimicrobial Wound Solution
FDA 510(k)
FDA Unclassified
·Unknown
Promogran Prisma Collagen Matrix with ORC and Silver
FDA 510(k)
FDA Unclassified
·Unknown
LUOFUCON® Antimicrobial Wound Gel
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Tyco Healthcare
| K Number | Device Name | ||
|---|---|---|---|
| K071049 | DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR | Oct 16, 2007 | Substantially Equivalent |
| K070685 | KENDALL ANTIMICROBIAL DRAIN DRESSING FOR OTC USE, MODEL 6662 | Sep 14, 2007 | Substantially Equivalent |
| K061492 | MONOJECT MAGELLAN INSULIN AND TUBERCULIN SAFETY SYRINGE | Aug 3, 2006 | Substantially Equivalent |
| K042709 | DOVER SILVER TEMPERATURE SENSING FOLEY CATHETER | Jan 18, 2005 | Substantially Equivalent |
| K040897 | DOVER ROB-NEL CATHETER | Jul 20, 2004 | Substantially Equivalent |
| K040649 | KENDALL SCD EXPRESS KAMBIA THIGH LENGTH TEARAWAY SLEEVE | Jul 15, 2004 | Substantially Equivalent |
| K041243 | DOVER RED RUBBER ROBINSON CATHETER | Jul 7, 2004 | Substantially Equivalent |
| K032438 | MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE, MONOJET PREFILL HEPRIN LOCK FLUSH SYRINGE | Jun 30, 2004 | Substantially Equivalent |
| K033453 | KENDALL ULTEC PRO AG+ HYDROCOLLOID DRESSING | Apr 29, 2004 | Substantially Equivalent |
| K032827 | KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501 | Dec 8, 2003 | Substantially Equivalent |