SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long
by Sumitomo Bakelite Co., Ltd.
510(k) K152771
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK152771 | Date17 Jun 2016 | StatusActive |
Recalls
-
- Terminated Z-0388-2017
Mislabeled product: Sterilization pouch and carton box labeled as Standard type instead of Jr type-Long
-
- Terminated Z-0389-2017
Mislabeled product: Sterilization pouch and carton labeled as Standard Type instead of Short type
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KNS
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.4300
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The SB Knife Jr, SB Knife Short, SB Knife Standard, and SB Knife Jr - Long are single-use, sterile electrosurgical knives designed for endoscopic procedures. These devices are classified as endoscopic electrosurgical units with or without accessories and are intended for precise tissue cutting and coagulation during gastrointestinal interventions.
Used in conjunction with monopolar high-frequency generators and patient grounding plates, these knives deliver controlled electrical current to facilitate cutting and hemostasis. Supplied sterile and intended for single-use, they are available in multiple types tailored for specific anatomical regions, including the esophagus, large bowel (narrow lumen), and stomach. The devices comply with FDA 510(k) clearance under the classification of Class II medical devices.
Other devices from Sumitomo Bakelite Co., Ltd.
Questions
AI-generated answers, 19 Sep 2026
Are these SB Knife models designed for reusable or single-use applications, and how does that affect their use in endoscopic procedures?
The SB Knife Jr, SB Knife Short, SB Knife Standard, and SB Knife Jr - Long are explicitly designed for single-use only. This design ensures sterility and safety during endoscopic procedures, as reuse could compromise integrity and introduce infection risks. Their sterile packaging and intended use with monopolar high-frequency generators align with best practices for endoscopic electrosurgical tools.
What anatomical regions are these SB Knife models specifically tailored for, and how does the length or type differentiate their use?
These knives are tailored for specific anatomical regions in gastrointestinal interventions: the SB Knife Jr and SB Knife Jr - Long are designed for the esophagus and narrow lumens (e.g., large bowel), while the SB Knife Short and SB Knife Standard are optimized for broader areas like the stomach. The variations in length and type ensure precise cutting and coagulation in confined or larger spaces, respectively.
How are these SB Knife models supplied, and what should clinicians verify before use to ensure proper functionality?
The SB Knife models are supplied sterile and pre-packaged, ready for immediate single-use. Clinicians should verify the sterility seal is intact and confirm compatibility with their monopolar high-frequency generator and patient grounding plate—both critical for controlled electrical current delivery during endoscopic procedures. Always check the packaging for expiration dates or damage.
What regulatory pathway does this device follow, and which advisory committees were involved in its evaluation?
These SB Knife models follow the FDA 510(k) clearance pathway, classified as Class II medical devices under the product code *KNS* (Endoscopic Electrosurgical Units). The evaluation involved the Gastroenterology and Urology (GU) Advisory Committee, reflecting their intended use in gastrointestinal and urological endoscopic procedures. The clearance was granted under *Substantially Equivalent* determination.