Valleylab, Inc.: FDA clearances and approvals
Valleylab, Inc. has 104 FDA 510(k) clearances (first 1976, latest 2009), across 15 product codes in 5 review panels. Median 510(k) review time: 65 days. openFDA lists 2 product recalls by a recalling firm named Valleylab, Inc.
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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 69 | 69 |
| LFL | Instrument, Ultrasonic Surgical | 9 | 9 |
| FRN | Pump, Infusion | 7 | 7 |
| FPA | Set, Administration, Intravascular | 4 | 4 |
| HGI | Electrocautery, Gynecologic (And Accessories) | 3 | 3 |
| GEH | Unit, Cryosurgical, Accessories | 2 | 2 |
| LBK | Neurosurgical Ultrasonic Instruments | 2 | 2 |
| BWA | Unit, Electrosurgical And Coagulation, With Accessories | 1 | 1 |
| DRX | Electrode, Electrocardiograph | 1 | 1 |
| FYD | Apparatus, Exhaust, Surgical | 1 | 1 |
Plus 5 more product codes.
Review panels
- General and Plastic Surgery (83)
- General Hospital (12)
- Neurology (4)
- Obstetrics and Gynecology (4)
- Cardiovascular (1)
Most recent Valleylab, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K092879 | LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER-DIVIDER | GEI | 2009-10-16 | 28 |
| K063195 | LIGASURE ADVANCE LAPAROSCOPIC SEALER/DIVIDER WITH DISSECTING ELECTRODE, MODELS LF5034 AND LF5044 | GEI | 2006-11-29 | 40 |
| K053535 | VIVAWAVE MICROWAVE ABLATION SYSTEM | NEY | 2006-04-27 | 129 |
| K053290 | COOL-TIP RF GENERATOR, COOL-TIP RF SYSTEM ACCESSORIES | GEI | 2006-03-15 | 110 |
| K052796 | COOL-TIP RF GENERATOR, COOL-TIP RF SYSTEM ACCESSORIES | GEI | 2006-02-03 | 123 |
| K051644 | VALLEYLAB FORCETRIAD ELECTROSURGICAL GENERATOR | GEI | 2005-08-11 | 52 |
| K051627 | VALLEYLAB G3000 ELECTROSURGICAL INSTRUMENT | GEI | 2005-07-22 | 32 |
| K043273 | LIGASURE VESSEL SEALING SYSTEM. LIGASURE INSTRUMENTS | GEI | 2005-01-05 | 40 |
| K042216 | COOL-TIP RF ABLATION SYSTEM | GEI | 2004-11-12 | 88 |
| K041587 | LIGASURE PRECISE MODEL #LS1200/LIGASURE 5MM LAPAROSCOPIC SEALER DIVIDER MODEL # LS1500 | GEI | 2004-09-28 | 106 |
94 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2003-07-16.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Valleylab, Inc.'s product codes (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
Frequently asked questions
How many FDA 510(k) clearances does Valleylab, Inc. have?
Valleylab, Inc. has 104 FDA 510(k) clearances (first 1976, latest 2009), across 15 product codes in 5 review panels.
How long does FDA take to clear Valleylab, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Valleylab, Inc.'s cleared 510(k)s is 65 days.
What devices does Valleylab, Inc. make?
Its most frequent FDA product codes are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 69); LFL (Instrument, Ultrasonic Surgical, 9); FRN (Pump, Infusion, 7).
Has Valleylab, Inc. had device recalls?
openFDA lists 2 product recalls in 1 recall event by a recalling firm whose name matches Valleylab, Inc; the most recent began 2003-07-16. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 104 Valleylab, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Valleylab, 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.