FDA product code BWN: Table And Attachments, Operating-Room
BWN is the FDA product code for table and attachments, operating-room. It is a Class I device, regulated under 21 CFR 878.4950 and reviewed by the General and Plastic Surgery panel. FDA has cleared 20 510(k) submissions under BWN, from 19 different applicants. The average 510(k) review took 60 days (median 32). FDA has posted 74 recalls for BWN devices.
Classification
| Field | Value |
|---|---|
| Device name | Table And Attachments, Operating-Room |
| Device class | Class I |
| Regulation | 21 CFR 878.4950 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every BWN clearance
Top BWN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Northwest Surgical Concepts, Inc. | 2 | 1981-11-20 |
| Alpha Surgical, Inc. | 1 | 1994-07-13 |
| Infinitech, Inc. | 1 | 1994-02-07 |
| Instrumentation Specialties, Inc. | 1 | 1993-04-29 |
| Yamashita and Hemsley Business Trust | 1 | 1993-02-10 |
14 more applicants have BWN clearances. See the full list in Caduvo.
Most recent BWN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K942699 | Alpha Surgical, Inc. | AIRFRAME SURGICAL DRAPE SUPPORT | 1994-07-13 | 35 |
| K935441 | Infinitech, Inc. | INFINITECH BREATH EZ | 1994-02-07 | 87 |
| K925005 | Instrumentation Specialties, Inc. | ISI SELF-SUPPORTING ARM | 1993-04-29 | 209 |
| K922288 | Yamashita and Hemsley Business Trust | HOLDER, PEDIATRIC POSITION | 1993-02-10 | 271 |
| K910783 | Smith & Nephew Equipment Group | SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M | 1991-04-02 | 36 |
Recalls for BWN devices
74 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-09-13.
| Year | Recalls |
|---|---|
| 2021 | 1 |
Frequently asked questions
What is FDA product code BWN?
BWN is the FDA product code for table and attachments, operating-room. It is a Class I device, regulated under 21 CFR 878.4950 and reviewed by the General and Plastic Surgery panel.
What device class is BWN?
Class I, regulation 21 CFR 878.4950. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code BWN?
Across 20 cleared submissions the average was 60 days from receipt to decision (median 32).
Which companies have the most BWN clearances?
Northwest Surgical Concepts, Inc. (2); Alpha Surgical, Inc. (1); Infinitech, Inc. (1); Instrumentation Specialties, Inc. (1); Yamashita and Hemsley Business Trust (1).
Have BWN devices been recalled?
Yes: 74 product recalls across 3 recall events; the most recent began 2021-09-13.
Next steps
- Run an FDA pathway report with predicate devices for product code BWN
- Run a recall and safety report across every BWN manufacturer
- Watch product code BWN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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