The Tulip Mfg. Co.: FDA clearances and approvals
The Tulip Mfg. Co. has 24 FDA 510(k) clearances (first 1995, latest 1996), across 4 product codes in 2 review panels. Median 510(k) review time: 126 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 19 | 19 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 3 | 3 |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | 1 | 1 |
| GCT | Light Source, Endoscope, Xenon Arc | 1 | 1 |
Review panels
Most recent The Tulip Mfg. Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K952959 | THE TULIP LAPAROSCOPE SHEATH 6MM DUAL STOPCOCK | GCJ | 1996-01-22 | 210 |
| K952906 | THE TULIP LAPAROSCOPE SHEATH 6MM SINGLE STOPCOCK | GCJ | 1996-01-22 | 213 |
| K955502 | THE TULIP MONO POLAR ROTATABLE METZ SCISSORS | GEI | 1996-01-17 | 47 |
| K955501 | THE TULIP MONO POLAR ROTATABLE ALLIGATOR FORCEP | GEI | 1996-01-17 | 47 |
| K954734 | THE TULIP LCI-200 ILLUMINATION & IMAGING SYSTEM (MODIFICATION) | FET | 1995-11-14 | 42 |
| K952958 | THE TULIP COMPANY BRANSON OVERSHEATH | GCJ | 1995-11-14 | 141 |
| K952953 | THE TULIP CXOMPANY BRANSON #2 ELEVATOR | GCJ | 1995-11-14 | 141 |
| K952951 | THE TULIP COMPANY BRASON NERVE HOOK & DISSECTOR | GCJ | 1995-11-14 | 141 |
| K952932 | THE TULIP COMPANY BRANSON #1 ELEVATOR | GCJ | 1995-11-14 | 141 |
| K952902 | THE TULIP COMPANY BRANSON POSTERIOR DISSECTOR | GCJ | 1995-11-14 | 144 |
14 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named The Tulip Mfg. Co..
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 The Tulip Mfg. Co. have?
The Tulip Mfg. Co. has 24 FDA 510(k) clearances (first 1995, latest 1996), across 4 product codes in 2 review panels.
How long does FDA take to clear The Tulip Mfg. Co.'s 510(k)s?
The median time from FDA receipt to decision across The Tulip Mfg. Co.'s cleared 510(k)s is 126 days.
What devices does The Tulip Mfg. Co. make?
Its most frequent FDA product codes are GCJ (Laparoscope, General & Plastic Surgery, 19); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 3); FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology, 1).
Has The Tulip Mfg. Co. had device recalls?
openFDA lists no recalls under a recalling firm name matching The Tulip Mfg. Co. Related entities may recall under other names.
Next steps
- See all 24 The Tulip Mfg. Co. clearances with predicates and recalls
- Run predicate analysis for product code GCJ, The Tulip Mfg. Co.'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.