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Suture, Recombinant Technology

Page Type
Product Code
Definition
Intended for use in soft tissue approximation. Indicated for use in general soft tissue approximation and/or ligation.
Physical State
Polymer (solid)
Technical Method
Produced through recombinant DNA technology
Target Area
General soft tissues in the body.
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.4494
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4494 Absorbable poly(hydroxybutyrate) surgical suture produced by recombinant DNA technology

§ 878.4494 Absorbable poly(hydroxybutyrate) surgical suture produced by recombinant DNA technology.

(a) Identification. An absorbable poly(hydroxybutyrate) surgical suture is an absorbable surgical suture made of material isolated from prokaryotic cells produced by recombinant deoxyribonucleic acid (DNA) technology. The device is intended for use in general soft tissue approximation and ligation.

(b) Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology.” For the availability of this guidance document see § 878.1(e).

[72 FR 43146, Aug. 3, 2007]

Suture, Recombinant Technology

Page Type
Product Code
Definition
Intended for use in soft tissue approximation. Indicated for use in general soft tissue approximation and/or ligation.
Physical State
Polymer (solid)
Technical Method
Produced through recombinant DNA technology
Target Area
General soft tissues in the body.
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.4494
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4494 Absorbable poly(hydroxybutyrate) surgical suture produced by recombinant DNA technology

§ 878.4494 Absorbable poly(hydroxybutyrate) surgical suture produced by recombinant DNA technology.

(a) Identification. An absorbable poly(hydroxybutyrate) surgical suture is an absorbable surgical suture made of material isolated from prokaryotic cells produced by recombinant deoxyribonucleic acid (DNA) technology. The device is intended for use in general soft tissue approximation and ligation.

(b) Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology.” For the availability of this guidance document see § 878.1(e).

[72 FR 43146, Aug. 3, 2007]