Search Results
Found 1 results
510(k) Data Aggregation
K Number
K133499Device Name
SUZHOU BEINUO SURGICAL STAPLERS - CIRCULAR STAPLERS FOR SINGLE USE, HEMORRHOIDAL CIRCULAR STAPLERS FOR SINGLE USE, LINEA
Manufacturer
Date Cleared
2014-01-14
(61 days)
Product Code
Regulation Number
878.4750Why did this record match?
Applicant Name (Manufacturer) :
SUZHOU BEINUO MEDICAL EQUIPMENT CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Suzhou Beinuo surgical staplers are indicated for use as follows:
· Circular Stapler for Single Use
The Suzhou Beinuo Circular Staple Use is used throughout the alimentary tract for the reconstruction of the alimentary tract and the creation of end-to-end, end-to-side and side-to-side anastomoses.
· Hemorrhoidal Circular Stapler for Single Use
The Suzhou Beinuo Hemorthoidal Circular Staple Use is a Circular Stapler product, with accessories, that is indicated in anorectal surgical procedures for the treatment of hemorrhoids and anorectal wall defects.
· Linear Stapler and Reloads for Single Use
The Suzhou Beinuo Linear Stapler and Reloads for Single Use (and reloads) is indicated for the closure of tissue in abdominal, gynecological, and thoracic surgical procedures.
· Linear Cutter Stapler and Reloads for Single Use
The Suzhou Beinuo Linear Cutter Staple Use (and reloads) is indicated for use in the resection, transection, transection and anastomosis of tissue in gastrointestinal, gynecological, and thoracic surgical procedures.
Device Description
The Suzhou Beinuo Staplers were designed in reference to the general principles of surgical staplers. Each stapler/ instrument is activated by squeezing the handle firmly as far as it will go or by pushing the firing knob as far as it will go. Specifics for each stapler include:
- The Suzhou Beinuo Circular Stapler for Single Use places a circular, double staggered row of titanium staples. Immediately after staple formation, the instrument's central knife blade resects the excess tissue, creating a circular anastomosis. The diameter of the staple line is determined by the selection of the 21mm, 28mm, or 32mm stapler. Note that there are two product codes for this stapler (SBW and SBCS L). The total length of SBW stapler is 420mm and the total length of SBCS L version is 520mm. The staplers are identical except for the length.
- The Suzhou Beinuo Hemorrhoidal Circular Staplers for Single Use places two circular peripheral lines of alternating and overlapping staples, thereby sealing off the rectal tissue above the anal canal. The central circular cutting blade cuts the surplus tissue after the sealing to reconstruct the rectal tissue. The diameter of the staple line is determined by the selection of the 32mm or 34mm stapler.
- The Suzhou Beinuo Linear Staplers and Reloads for Single Use places a double(or triple in the case of the SBF 30B) staggered row of titanium staples used for mechanical suturing and closure of tissue. The Linear Stapler is available in 32mm, 60mm, and 88mm line lengths for use in various applications. The instrument may be reloaded during a single procedure.
- The Suzhou Beinuo Linear Cutter Staplers and Reloads for Single Use delivers two doubled staggered rows of titanium staples and anastomoses the internal tissues and incisions during surgical procedures. The Linear Cutter stapler is available in three staple line lengths (61mm, 81mm, or 101mm). The instrument may be reloaded during a single procedure.
Ask a Question
Ask a specific question about this device
Page 1 of 1