Davis & Geck, Inc.: FDA filings under this applicant name
FDA lists 45 510(k) clearances under the applicant name “Davis & Geck, Inc.” (first 1981, latest 1999), plus 1 PMA decision, across 29 product codes in 6 review panels. Median 510(k) review time under this name: 73 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GAG | Stapler, Surgical | 4 | 4 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 4 | 4 |
| GCJ | Laparoscope, General & Plastic Surgery | 4 | 4 |
| FZP | Clip, Implantable | 3 | 3 |
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | 2 | 2 |
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | 2 | 2 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 2 | 2 |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | 2 | 2 |
| GDW | Staple, Implantable | 2 | 2 |
| LDF | Electrode, Pacemaker, Temporary | 2 | 2 |
Plus 19 more product codes.
Review panels
- General and Plastic Surgery (34)
- Cardiovascular (5)
- General Hospital (3)
- Anesthesiology (1)
- Gastroenterology and Urology (1)
- Orthopedic (1)
Most recent Davis & Geck, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K982853 | SILK SUTURE | GAP | 1999-04-30 | 260 |
| K981582 | SURGILON, DERMALON, & OPHTHALON | GAR | 1998-07-13 | 70 |
| K980610 | DEXON RAPID (DEXON R) | GAM | 1998-05-18 | 90 |
| K974015 | ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL CATHETER- PICC TRAYS, ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL | FOZ | 1998-05-18 | 208 |
| K980062 | MONOJECTT BLUNTIP I.V. ACCESS CANNULA WITH VIAL ACCESS PIN DEVICE | FMI | 1998-03-20 | 72 |
| K973409 | KANGAROO ENTERAL FEEDING EXTENSION SET FOR SYRINGE PUMPS | KNT | 1998-02-27 | 171 |
| K970857 | ARGYLE AQUA-SEAL ALL PURPOSE AUTOTRANSFUSION CHEST DRAINAGE UNIT AND OPTIONAL ARGYLE AQUA-SEAL EVACUATING AUTOTRANSFUSIO | CAC | 1997-11-05 | 240 |
| K972139 | ASPR-CARE CLOSED SYSTEM,DUAL SWIVEL PIECE T,SHEATHED SUCTION CATHETER,BRONCHOSOPE ADAPTER,IN-LINE SPECIMEN TRAP | BTM | 1997-09-03 | 89 |
| K972566 | DEXON VIOLET | GAM | 1997-08-14 | 36 |
| K962971 | POLYPROPYLENE MESH (VARIOUS SIZES) | FTL | 1996-09-16 | 47 |
35 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| N17433 | PMA | PRE OP SPONGE | 1978-10-12 |
Recalls
openFDA lists no recalls under a recalling firm named Davis & Geck, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Davis Schottlander & Davis, Ltd. (7 510(k)s)
- Davis Lead Aprons, Inc. (3 510(k)s)
- Davis Assoc. (1 510(k)s)
- Davis Medical (1 510(k)s)
- Davis Positioning Systems, Inc. (1 510(k)s)
- Davis-Smith Corp. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Davis & Geck, Inc.?
FDA lists 45 510(k) clearances under the applicant name “Davis & Geck, Inc.” (first 1981, latest 1999), plus 1 PMA decision, across 29 product codes in 6 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Davis & Geck, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Davis & Geck, Inc. is 73 days.
Which FDA product codes appear under Davis & Geck, Inc.?
The most frequent FDA product codes under this applicant name are GAG (Stapler, Surgical, 4); GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid, 4); GCJ (Laparoscope, General & Plastic Surgery, 4).
Next steps
- See all 45 Davis & Geck, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GAG, Davis & Geck, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.