Surgical Specialties Corp
US Last updated 23 May 2026
- Devices
- 32
- Registries
- FDA 510(k)
- FDA recalls
- 91 ongoing
Catalogue
Monoderm Ref K040477
Suture Absorbable- Gut Ref K932037
S3 Medicated Gauze Ref K874219
S1 Nasal Packing Ref K861444
Suture Nonabsorbable- Silk, Polyester Ref K932038
S1 Oral Packing Ref K861446
Contour Forehead/Browlift Thread Ref K042856
Monoderm Surgical Suture Ref K140227
S1 Vaginal Packing Ref K861443
Featherlift Extended Length Aptos Thread Ref K041593
S1 Cavity Packing Ref K861445
Optimized Barb Design Ref K052962
LOOK PTFE Suture Ref K160744
Contour Necklift Threads Ref K050247
Contour Midface Opposing Uni-Directional Threads Ref K050548
Look Collagen Spacers, Model 1514B Ref K001765
Sharpoint Pdo (Polydioxanone) Sutures Ref K063680
Suture Nonabsorbable - Silk Ref K930826
Sharpoint Ultraplug Extended Wear Plug Ref K020882
Polysyn Surgical Suture Ref K141625
Sharpoint Lukens Bone Wax Ref K050292
FDA recalls
Surgical Specialties Corp has nine FDA recall records initiated between November 5, 2002, and March 26, 2024. The records include open, classified, and terminated statuses, with reasons involving labeling errors such as incorrect text, mislabeling of product composition (e.g., suture type or size), incorrect needle curvature, and incorrect sterilization methods. Some records also note discrepancies where the wrong product was included in packaging or units were mislabeled as double-armed when they were single-armed.
2024
- 26 Mar 2024 Z-1534-2024 Class II Ongoing Complaints have been received with allegations of Incorrect Needle Curvature.
2011
- 30 Mar 2011 Z-2138-2011 Unclassified (pre-2012) Terminated Mislabeled - a number of units of the product labeled as 4-0 Black Mono Nylon suture product contain a 4-0 Black Braided Silk suture.
2008
- 9 Sep 2008 Z-0034-2009 Unclassified (pre-2012) Terminated mislabeled product - labeled as 3-0 black mono nylon contains 4-0 black braided silk suture
2005
- 24 Sep 2005 Z-0085-06 Unclassified (pre-2012) Terminated mislabeled as double armed straight needle actually single armed straight needle
2003
- 25 Aug 2003 Z-0936-04 Unclassified (pre-2012) Terminated sterilization method incorrect
- 21 Aug 2003 Z-0026-04 Unclassified (pre-2012) Terminated text on product handle is incorrect
- 7 Jan 2003 Z-0705-03 Unclassified (pre-2012) Terminated size mislabeled on product handle
2002
- 5 Nov 2002 Z-0543-03 Unclassified (pre-2012) Terminated The wrong product in the box.
- 5 Nov 2002 Z-0544-03 Unclassified (pre-2012) Terminated The wrong product in the box.
What Surgical Specialties Corp makes
Surgical Specialties Corp manufactures synthetic absorbable surgical sutures, including monofilament and braided variants, as well as specialized barbed threads for soft tissue approximation. Their portfolio includes microkeatome blades for precise tissue dissection and collagen spacers for reconstructive procedures. Additional products feature PDO-based threads for procedures like browlifts, necklifts, and midface rejuvenation, designed for extended retention and controlled tissue remodeling.
The company’s devices are classified under FDA categories Class I, Class II, and Unclassified (U), with most submissions supported via 510(k) clearances. Products are listed in the FDA’s 510(k) registry, reflecting their regulatory pathway in the United States. The manufacturer operates from the US, adhering to domestic medical device regulations.
Frequently asked questions
What types of medical devices does Surgical Specialties Corp manufacture?
Surgical Specialties Corp specializes in synthetic absorbable surgical sutures, including both monofilament and braided varieties. Their product line also includes specialized barbed threads for soft tissue approximation, microkeatome blades for precise tissue dissection, and collagen spacers used in reconstructive procedures. Additionally, they offer PDO-based threads designed for procedures like browlifts, necklifts, and midface rejuvenation, which provide extended retention and controlled tissue remodeling.
Where is Surgical Specialties Corp based, and does that affect its regulatory compliance?
Surgical Specialties Corp is based in the United States. Since the company operates domestically, its devices are subject to FDA regulations, including classification under FDA categories such as Class I, Class II, and Unclassified (U). The regulatory pathway for these devices is primarily supported by 510(k) clearances, which are documented in the FDA’s 510(k) registry.
Which regulatory registries list Surgical Specialties Corp’s devices?
Surgical Specialties Corp’s devices are listed in the FDA’s 510(k) registry. This registry reflects the regulatory pathway for their products in the United States, where most submissions are cleared via the 510(k) process. The inclusion in this registry indicates that these devices have undergone the necessary evaluations to meet FDA requirements for marketing in the US.
How are Surgical Specialties Corp’s devices classified by the FDA?
The FDA classifies Surgical Specialties Corp’s devices into three categories: Class I, Class II, and Unclassified (U). The classification depends on the risk associated with each device—Class I typically includes low-risk items, Class II involves moderate-risk devices requiring special controls, and Unclassified (U) refers to devices that do not fit neatly into the other categories but still require regulatory oversight. Most of their submissions, such as sutures and microkeatome blades, fall under these classifications.
Information
- Country
- US