FDA product code FWZ: Operating Room Accessories Table Tray
FWZ is the FDA product code for operating room accessories table tray. It is a Class I device, regulated under 21 CFR 878.4950 and reviewed by the General and Plastic Surgery panel. FDA has cleared 61 510(k) submissions under FWZ, from 34 different applicants. The average 510(k) review took 38 days (median 26). FDA has posted 37 recalls for FWZ devices, 1 initiated in the last five years.
Definition
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Classification
| Field | Value |
|---|---|
| Device name | Operating Room Accessories Table Tray |
| 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 FWZ clearance
Top FWZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Mcconnell Orthopedic | 14 | 1991-02-21 |
| Orthopedic Systems, Inc. | 8 | 1991-01-24 |
| D.L. Nelson and Assoc., Inc. | 3 | 1994-11-22 |
| Lincoln Mills, Inc. | 2 | 1990-01-12 |
| Edgewater Medical Equipment Systems | 2 | 1987-09-11 |
29 more applicants have FWZ clearances. See the full list in Caduvo.
Most recent FWZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K960019 | Biopsys Medical, Inc. | RETRACTOR ARM CLAMP | 1996-02-09 | 38 |
| K945415 | D.L. Nelson and Assoc., Inc. | 'LIL MAC ACCESSORY CLAMP(TM) | 1994-11-22 | 15 |
| K944779 | Allen Medical Systems, Inc. | CARBON LIGHTS HAND SURGERY TABLE | 1994-10-14 | 17 |
| K935381 | Andronic Devices, Ltd. | KAPS POSITIONING ARM | 1994-04-15 | 158 |
| K931037 | Whitmore Ent., Inc. | WHITMORE VACUUM-LOCK SPINAL FRAME (VLSF-100) | 1993-07-30 | 151 |
Recalls for FWZ devices
37 product recalls in 19 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-02-14.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code FWZ?
FWZ is the FDA product code for operating room accessories table tray. 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 FWZ?
Class I, regulation 21 CFR 878.4950. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FWZ?
Across 61 cleared submissions the average was 38 days from receipt to decision (median 26).
Which companies have the most FWZ clearances?
Mcconnell Orthopedic (14); Orthopedic Systems, Inc. (8); D.L. Nelson and Assoc., Inc. (3); Lincoln Mills, Inc. (2); Edgewater Medical Equipment Systems (2).
Have FWZ devices been recalled?
Yes: 37 product recalls across 19 recall events; the most recent began 2024-02-14.
Next steps
- Run an FDA pathway report with predicate devices for product code FWZ
- Run a recall and safety report across every FWZ manufacturer
- Watch product code FWZ 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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