FDA 510(k)
FDA unclassified
Substantially Equivalent for Some Indications
🇺🇸 United States
BARD OCCLUSIVE WOUND DRESSING
K Number: K850889
·
Decision Jul 5, 1985
Classifications
1
FEI Numbers
384
Registration Numbers
385
Same Product Code
702
Applicant Total
645
Review Days
123
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
- BARD OCCLUSIVE WOUND DRESSING
- K Number
- K850889
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- C.R. Bard, Inc.
- Date Received
- March 4, 1985
- Decision Date
- July 5, 1985
- 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 C.R. Bard, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K254076 | BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter Kit | May 29, 2026 | Unknown |
| K252971 | Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories) | Mar 17, 2026 | Substantially Equivalent |
| K251864 | Rubber Utility Catheter | Feb 23, 2026 | Substantially Equivalent |
| K251186 | Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) | May 15, 2025 | Substantially Equivalent |
| K241334 | Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH Temporary Pacing Electrode Catheter, | Jan 31, 2025 | Substantially Equivalent |
| K230356 | Aspirex Thrombectomy System | Mar 31, 2023 | Substantially Equivalent |
| K223177 | Highlander 014 PTA Balloon Dilatation Catheter | Jan 20, 2023 | Substantially Equivalent |
| K222793 | WavelinQ Generator | Oct 17, 2022 | Substantially Equivalent |
| K220270 | Aspirex Thrombectomy System | Jun 21, 2022 | Substantially Equivalent |
| K213203 | Provena(TM) Midline Catheter | May 13, 2022 | Substantially Equivalent |