Davis & Geck, Inc.: FDA clearances and approvals
Davis & Geck, Inc. has 45 FDA 510(k) clearances (first 1981, latest 1999), plus 1 PMA decision, across 29 product codes in 6 review panels. Median 510(k) review time: 73 days.
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 company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Davis & Geck, Inc. have?
Davis & Geck, Inc. has 45 FDA 510(k) clearances (first 1981, latest 1999), plus 1 PMA decision, across 29 product codes in 6 review panels.
How long does FDA take to clear Davis & Geck, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Davis & Geck, Inc.'s cleared 510(k)s is 73 days.
What devices does Davis & Geck, Inc. make?
Its most frequent FDA product codes are GAG (Stapler, Surgical, 4); GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid, 4); GCJ (Laparoscope, General & Plastic Surgery, 4).
Has Davis & Geck, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Davis & Geck, Inc. Related entities may recall under other names.
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. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.