Spembly Medical , Ltd.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Spembly Medical , Ltd.” (first 1976, latest 1993), across 7 product codes in 3 review panels. Median 510(k) review time under this name: 47 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 |
|---|---|---|---|
| GEH | Unit, Cryosurgical, Accessories | 8 | 8 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 3 | 3 |
| GXH | Device, Surgical, Cryogenic | 2 | 2 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| HPS | Unit, Cryophthalmic | 1 | 1 |
| HQO | Unit, Cautery, Thermal, Ac-Powered | 1 | 1 |
| LFL | Instrument, Ultrasonic Surgical | 1 | 1 |
Review panels
- General and Plastic Surgery (10)
- Neurology (5)
- Ophthalmic (2)
Most recent Spembly Medical , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K925129 | SELECTOR | GCJ | 1993-04-23 | 192 |
| K903303 | SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBES | HPS | 1990-10-11 | 79 |
| K901974 | SELECTOR ULTRASONIC SURGICAL ASPIRATOR | LFL | 1990-09-05 | 127 |
| K882568 | 130 CRYO UNIT & ASSOC. CRYOPROBES & SPRAY | GEH | 1988-09-27 | 97 |
| K882963 | SPEMBLY MEDICAL 142 CRYO UNIT | GEH | 1988-08-08 | 25 |
| K882962 | SERIES 40 & SERIES 42 CRYOPROBES (R SERIES) | GEH | 1988-08-08 | 25 |
| K874367 | VARIOUS CARDIAC CRYOPROBES HAVING DIA. & COS. DIFF | HQO | 1988-01-04 | 73 |
| K840497 | OBSTETRIC PULSAR TWO CHANNEL TENS | GZJ | 1984-04-16 | 70 |
| K832385 | CRYOPROBES MC-1400-CRYOSURG-CONSOLE | GEH | 1983-09-12 | 55 |
| K832334 | CRYOMEDICS 5000 CRYOSURGICAL CONSOLE | GEH | 1983-08-12 | 25 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Spembly Medical , Ltd..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Spembly Medical , Ltd.?
FDA lists 17 510(k) clearances under the applicant name “Spembly Medical , Ltd.” (first 1976, latest 1993), across 7 product codes in 3 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 Spembly Medical , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Spembly Medical , Ltd. is 47 days.
Which FDA product codes appear under Spembly Medical , Ltd.?
The most frequent FDA product codes under this applicant name are GEH (Unit, Cryosurgical, Accessories, 8); GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 3); GXH (Device, Surgical, Cryogenic, 2).
Next steps
- See all 17 Spembly Medical , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GEH, Spembly Medical , Ltd.'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.