Surgical Innovations Plc: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Surgical Innovations Plc” (first 1996, latest 2013), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 178 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 | 2 | 188 |
| 2013 | 1 | 106 |
| 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 | 4 | 4 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | 2 |
| HIF | Insufflator, Laparoscopic | 1 | 1 |
Review panels
Most recent Surgical Innovations Plc 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K123110 | PRETZELFLEX SURGICAL RETRACTOR MODEL SHR7301 | GCJ | 2013-01-17 | 106 |
| K112659 | SURGICAL RETRACTORS | GCJ | 2012-03-09 | 178 |
| K111986 | LOGIC LAPAROSCOPIC INSTRUMENT SYSTEM | GEI | 2012-01-26 | 197 |
| K100109 | LOGIFLEX LAPAROSCOPIC BAND POSITIONING DEVICE | GCJ | 2010-07-15 | 182 |
| K063485 | LOGIC LAPAROSCOPIC SCISSORS | GEI | 2006-12-01 | 14 |
| K955393 | NUMO NM-1000 AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE | HIF | 1997-01-09 | 412 |
| K962193 | PORTLAND TROCARS | GCJ | 1996-08-28 | 82 |
Recalls
openFDA lists no recalls under a recalling firm named Surgical Innovations Plc.
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.
- Surgical Laser Technologies, Inc. (51 510(k)s)
- Surgical Specialties Corp (33 510(k)s)
- Surgical Technologies, Inc. (28 510(k)s)
- Surgical Navigation Technologies, Inc. (27 510(k)s)
- Surgical Instrument Service and Savings, Inc. (23 510(k)s)
- Surgical Dynamics, Inc. (12 510(k)s)
- Surgical Technology Laboratories, Inc. (12 510(k)s)
- Surgical Appliance Industries, Inc. (9 510(k)s)
- Surgical Instruments Service and Savings, Inc. (8 510(k)s)
- Surgical Theater, Inc. (8 510(k)s)
- Surgical Information Sciences, Inc. (7 510(k)s)
- Surgical Specialties Corp. Dba Angiotech (7 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Surgical Innovations Plc?
FDA lists 7 510(k) clearances under the applicant name “Surgical Innovations Plc” (first 1996, latest 2013), across 3 product codes in 2 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 Surgical Innovations Plc?
The median time from FDA receipt to decision across 510(k)s cleared under the name Surgical Innovations Plc is 178 days.
Which FDA product codes appear under Surgical Innovations Plc?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 4); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 2); HIF (Insufflator, Laparoscopic, 1).
Next steps
- See all 7 Surgical Innovations Plc clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Surgical Innovations Plc'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.