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510(k) Data Aggregation
K Number
K980623Device Name
N TECH DOUBLE PUNCTURE LAPAROSCOPE/N TECH OPERATING LAPAROSCOPE
Manufacturer
N-TECH ENDOSCOPY, INC.
Date Cleared
1998-04-30
(72 days)
Product Code
GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
N-TECH ENDOSCOPY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Laparoscopes, both the single and double puncture are for use when Gynecological Pelviscopy and Laparoscopic Cholecystectomy are medically indicated.
Device Description
Not Found
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K Number
K980592Device Name
NTECH CYSTOSCOPES
Manufacturer
N-TECH ENDOSCOPY, INC.
Date Cleared
1998-04-28
(70 days)
Product Code
FAJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
N-TECH ENDOSCOPY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Our Cystoscopes are used when Operative and/or Diagnostic Cystoscopy is medically indicated. Cystoscopes are used for 2 tasks: Providing an excellent visual image and good illumination of the operating area.
Device Description
We intend to manufacture our Cystoscopes under strict GMP Guidelines: From incoming material registration and testing to detailed manufacturing instructions and device master and history filing including complaint reporting.
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K Number
K980599Device Name
NTECH ARTHROSCOPE
Manufacturer
N-TECH ENDOSCOPY, INC.
Date Cleared
1998-04-15
(57 days)
Product Code
GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
N-TECH ENDOSCOPY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Operative and Diagnostic Arthroscopy for visual imiging and light transmission to the operative area.
The Arthroscopes are limited in their use to: Wrist, Knee, Shoulder and Ankle Surgery.
Device Description
Not Found
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