FDA product code GDZ: Handle, Scalpel
GDZ is the FDA product code for handle, scalpel. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 16 510(k) submissions under GDZ, from 15 different applicants. The average 510(k) review took 36 days (median 20). FDA has posted 13 recalls for GDZ devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Handle, Scalpel |
| Device class | Class I |
| Regulation | 21 CFR 878.4800 |
| 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 GDZ clearance
Top GDZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| The Huxley Instrument Corp. | 2 | 1985-07-15 |
| Spectra, Inc. | 1 | 2009-12-15 |
| Kinetic Medical Products | 1 | 1989-01-27 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 1988-11-17 |
| Precision Surgical Industries, Inc. | 1 | 1986-10-24 |
10 more applicants have GDZ clearances. See the full list in Caduvo.
Most recent GDZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K091462 | Spectra, Inc. | SPECTRA MEDICAL SAFETY SCAPEL | 2009-12-15 | 211 |
| K890242 | Kinetic Medical Products | SCALPEL HANDLE | 1989-01-27 | 9 |
| K884512 | Bd Becton Dickinson Vacutainer Systems Preanalytic | BEAVER(R) HANDLE | 1988-11-17 | 21 |
| K863951 | Precision Surgical Industries, Inc. | P.S.I.-DISPOSABLE SCALPEL SURGEONS HANDLE | 1986-10-24 | 14 |
| K863808 | S. Cordero Co. | THE S. CORDERO STYLUS | 1986-10-14 | 14 |
Recalls for GDZ devices
13 product recalls in 7 recall events; 3 initiated in the last five years and 2 still open. Most recent: 2024-12-03.
| Year | Recalls |
|---|---|
| 2022 | 1 |
| 2024 | 2 |
Frequently asked questions
What is FDA product code GDZ?
GDZ is the FDA product code for handle, scalpel. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel.
What device class is GDZ?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GDZ?
Across 16 cleared submissions the average was 36 days from receipt to decision (median 20).
Which companies have the most GDZ clearances?
The Huxley Instrument Corp. (2); Spectra, Inc. (1); Kinetic Medical Products (1); Bd Becton Dickinson Vacutainer Systems Preanalytic (1); Precision Surgical Industries, Inc. (1).
Have GDZ devices been recalled?
Yes: 13 product recalls across 7 recall events; the most recent began 2024-12-03.
Next steps
- Run an FDA pathway report with predicate devices for product code GDZ
- Run a recall and safety report across every GDZ manufacturer
- Watch product code GDZ 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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