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Gastroenterology-Urology Accessories To A Biopsy Instrument

Page Type
Product Code
Definition
A gastroenterology-urology accessory to a biopsy instrument is an accessory used to remove a specimen of tissue for microscopic examination by cutting or aspiration. This generic type of device includes a syringe for specimen aspiration and a biopsy channel adaptor. This device does not include accessories to biopsy instruments used in other medical specialty areas.
Physical State
Syringe for specimen aspiration and a biopsy channel adaptor
Technical Method
Syringe is used for specimen aspiration
Target Area
Gastrointestinal tract or urinary tract
Regulation Medical Specialty
Gastroenterology and Urology
Review Panel
Gastroenterology and Urology
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
876.1080
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 876.1080 Gastroenterology-urology accessories to a biopsy instrument

§ 876.1080 Gastroenterology-urology accessories to a biopsy instrument.

(a) Identification. A gastroenterology-urology accessory to a biopsy instrument is an accessory used to remove a specimen of tissue for microscopic examination by cutting or aspiration. This generic type of device includes a syringe for specimen aspiration and a biopsy channel adaptor. This device does not include accessories to biopsy instruments used in other medical specialty areas.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

[84 FR 14869, Apr. 12, 2019]

Gastroenterology-Urology Accessories To A Biopsy Instrument

Page Type
Product Code
Definition
A gastroenterology-urology accessory to a biopsy instrument is an accessory used to remove a specimen of tissue for microscopic examination by cutting or aspiration. This generic type of device includes a syringe for specimen aspiration and a biopsy channel adaptor. This device does not include accessories to biopsy instruments used in other medical specialty areas.
Physical State
Syringe for specimen aspiration and a biopsy channel adaptor
Technical Method
Syringe is used for specimen aspiration
Target Area
Gastrointestinal tract or urinary tract
Regulation Medical Specialty
Gastroenterology and Urology
Review Panel
Gastroenterology and Urology
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
876.1080
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 876.1080 Gastroenterology-urology accessories to a biopsy instrument

§ 876.1080 Gastroenterology-urology accessories to a biopsy instrument.

(a) Identification. A gastroenterology-urology accessory to a biopsy instrument is an accessory used to remove a specimen of tissue for microscopic examination by cutting or aspiration. This generic type of device includes a syringe for specimen aspiration and a biopsy channel adaptor. This device does not include accessories to biopsy instruments used in other medical specialty areas.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

[84 FR 14869, Apr. 12, 2019]