FDA product code HWQ: Passer
HWQ is the FDA product code for passer. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel. FDA has cleared 9 510(k) submissions under HWQ, from 7 different applicants. The average 510(k) review took 116 days (median 42). FDA has posted 8 recalls for HWQ devices.
Classification
| Field | Value |
|---|---|
| Device name | Passer |
| Device class | Class I |
| Regulation | 21 CFR 888.4540 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HWQ clearance
Top HWQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Acufex Microsurgical, Inc. | 2 | 1993-05-05 |
| Plastafil, Inc. | 2 | 1984-07-11 |
| Mitek Products | 1 | 1997-03-10 |
| Instrument Makar, Inc. | 1 | 1989-02-09 |
| Visitec Co. | 1 | 1984-10-05 |
2 more applicants have HWQ clearances. See the full list in Caduvo.
Most recent HWQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K970360 | Mitek Products | MITEK SUTURE RETROGRADER | 1997-03-10 | 38 |
| K923381 | Acufex Microsurgical, Inc. | SOFT TISSUE EXPANDER | 1993-05-05 | 300 |
| K920621 | Acufex Microsurgical, Inc. | ACUFEX PASSING PINS AND SURGICAL WIRE | 1993-05-05 | 449 |
| K885311 | Instrument Makar, Inc. | MENISCUS MENDER II LOOP | 1989-02-09 | 42 |
| K843592 | Visitec Co. | VICO MICRO SURGICAL INSTRUMENTS | 1984-10-05 | 23 |
Recalls for HWQ devices
8 product recalls in 6 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-04-01.
Frequently asked questions
What is FDA product code HWQ?
HWQ is the FDA product code for passer. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel.
What device class is HWQ?
Class I, regulation 21 CFR 888.4540. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HWQ?
Across 9 cleared submissions the average was 116 days from receipt to decision (median 42).
Which companies have the most HWQ clearances?
Acufex Microsurgical, Inc. (2); Plastafil, Inc. (2); Mitek Products (1); Instrument Makar, Inc. (1); Visitec Co. (1).
Have HWQ devices been recalled?
Yes: 8 product recalls across 6 recall events; the most recent began 2016-04-01.
Next steps
- Run an FDA pathway report with predicate devices for product code HWQ
- Run a recall and safety report across every HWQ manufacturer
- Watch product code HWQ 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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