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Instrument, Biopsy, Core, Soft Tissue, Female Reproductive Organs

Page Type
Product Code
Definition
Obtain core soft tissue biopsy samples of internal female reproductive organs such as uterus, ovaries, and retroperitoneal lymph nodes.
Physical State
Metal needle and cannula.
Technical Method
Manual rotation of needle and cannula to remove soft tissue for biopsy samples.
Target Area
Internal female reproductive organs (uterus, ovaries, retroperitoneal lymph nodes.
Regulation Medical Specialty
Gastroenterology and Urology
Review Panel
Obstetrical and Gynecological
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
876.1075
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 876.1075 Gastroenterology-urology biopsy instrument

§ 876.1075 Gastroenterology-urology biopsy instrument.

(a) Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

(b) Classification. (1) Class II (performance standards).

(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

[48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996; 66 FR 38801, July 25, 2001]

Instrument, Biopsy, Core, Soft Tissue, Female Reproductive Organs

Page Type
Product Code
Definition
Obtain core soft tissue biopsy samples of internal female reproductive organs such as uterus, ovaries, and retroperitoneal lymph nodes.
Physical State
Metal needle and cannula.
Technical Method
Manual rotation of needle and cannula to remove soft tissue for biopsy samples.
Target Area
Internal female reproductive organs (uterus, ovaries, retroperitoneal lymph nodes.
Regulation Medical Specialty
Gastroenterology and Urology
Review Panel
Obstetrical and Gynecological
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
876.1075
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 876.1075 Gastroenterology-urology biopsy instrument

§ 876.1075 Gastroenterology-urology biopsy instrument.

(a) Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

(b) Classification. (1) Class II (performance standards).

(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

[48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996; 66 FR 38801, July 25, 2001]