Surgical Specialties Corp: FDA filings under this applicant name
FDA lists 33 510(k) clearances under the applicant name “Surgical Specialties Corp” (first 1986, latest 2016), across 14 product codes in 4 review panels. Median 510(k) review time under this name: 38 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 | 4 | 29 |
| 2015 | 0 | — |
| 2016 | 1 | 118 |
| 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 |
|---|---|---|---|
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 8 | 8 |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | 5 | 5 |
| NEW | Suture, Surgical, Absorbable, Polydioxanone | 5 | 5 |
| EFQ | Gauze/Sponge, Internal | 4 | 4 |
| GAP | Suture, Nonabsorbable, Silk | 2 | 2 |
| FRO | Dressing, Wound, Drug | 1 | 1 |
| GAN | Suture, Absorbable, Synthetic | 1 | 1 |
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | 1 | 1 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 1 | 1 |
| HNO | Keratome, Ac-Powered | 1 | 1 |
Plus 4 more product codes.
Review panels
- General and Plastic Surgery (29)
- Ophthalmic (2)
- Orthopedic (1)
- Radiology (1)
Most recent Surgical Specialties Corp 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K160744 | LOOK PTFE Suture | NBY | 2016-07-13 | 118 |
| K141778 | QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN | GAM | 2014-07-30 | 28 |
| K141625 | POLYSYN SURGICAL SUTURE | GAM | 2014-07-18 | 31 |
| K141558 | QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE | GAM | 2014-07-11 | 29 |
| K140227 | MONODERM SURGICAL SUTURE | GAM | 2014-02-28 | 29 |
| K080985 | QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF POLYDIOXANONE (PDO) | NEW | 2008-04-23 | 16 |
| K080680 | QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF PDO (POLYDIOXANONE | NEW | 2008-03-21 | 11 |
| K071989 | QUILL SELF-RETAINING SYSTEM (SRS) SYNTHETIC ABSORBABLE SURGICAL SUTURE MATERIAL | NEW | 2007-08-06 | 17 |
| K072028 | QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF MONODERM | GAM | 2007-08-03 | 10 |
| K063680 | SHARPOINT PDO (POLYDIOXANONE) SUTURES | NEW | 2007-05-09 | 149 |
23 earlier clearances. See the full list in Caduvo.
Recalls
9 product recalls in 8 recall events; 1 initiated in the last five years. Most recent: 2024-03-26.
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 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 Innovations Plc (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 Specialties Corp?
FDA lists 33 510(k) clearances under the applicant name “Surgical Specialties Corp” (first 1986, latest 2016), across 14 product codes in 4 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 Specialties Corp?
The median time from FDA receipt to decision across 510(k)s cleared under the name Surgical Specialties Corp is 38 days.
Which FDA product codes appear under Surgical Specialties Corp?
The most frequent FDA product codes under this applicant name are GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid, 8); GAW (Suture, Nonabsorbable, Synthetic, Polypropylene, 5); NEW (Suture, Surgical, Absorbable, Polydioxanone, 5).
Next steps
- See all 33 Surgical Specialties Corp clearances with predicates and recalls
- Run predicate analysis for product code GAM, Surgical Specialties Corp'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.